In December of 2000, decades after ultrasound was approved by
the FDA for use in obstetric that Agency acknowledges that no one knows the
delayed, long term effects of diagnostic levels of ultrasound on human
development.

Millions of women and their unborn children are being exposed
to diagnostic ultrasound during pregnancy and childbirth without the women being
advised prior to exposure that there has been no well-controlled scientific
investigation carried out to study the delayed, long-term effects of ultrasound
on human development. Ova, embryos and fetuses are often exposed to prolonged
sonography because the physician or technician lacks sufficient expertise to
evaluate what he or she is seeing.

The FDA has yielded to pressure from industry and organized
medicine to relinquish control over the amount of sonic energy that can be
emitted by the new ultrasound devices used in obstetrics. The new ultrasound
machines will beep at certain levels of energy output but essentially there will
be little or no limit on the energy the health care provider may choose to use.

Despite the fact that the FDA's Center for Devices and
Radiologic Health acknowledged the potential risks of ultrasound used in
obstetrics in its 1982 publication "An Overview of Ultrasound", edited
by Stewart and Stratmeyer, there is no evidence that health care providers are
obtaining women's truly informed consent to the use of ultrasound in pregnancy.

There are no state or federal regulations which require
periodic calibration of ultrasound devices used in obstetric care. Nor are there
any regulations that require a record to be kept of basic information such as:

The indication for the
procedure

The written consent of the
patient

The name of the manufacturer
and the model number of the ultrasound equipment used

The type of ultrasound employed

The proposed intensity, as well
as the actual intensity of exposure

The proposed and actual length
of exposure

Maternal height, weight, and
temperature

Identification of the hospital
or the office where the procedure is carried out

Identification and
qualification of sonographer

Date of exposure

Numerous studies have been carried out to evaluate the
effectiveness of routine diagnostic ultrasound. None has shown the routine use
of diagnostic ultrasound to improve maternal and infant outcome over that
achieved when diagnostic ultrasound was used only when medically indicated.

Are women overly concerned regarding the safety of ultrasound
used in obstetrics? A letter published in the July 1988 issue of the British
Journal of Obstetrics and Gynaecology, from Dr. Robert Bases, Chief of the
Radiobiology Section, Albert Einstein College of Medicine, calls attention to
the 1984 review by Stewart and Moore of over 700 publications since 1950 which
demonstrate the present chaos in delineating and controlling exposure conditions
and the bewildering range of ultrasound bioeffects. Bases states in his letter:

"The increased frequency of sister chromatid
exchanges induced by pulsed ultrasound in human lymphocytes, first described
by Liebeskind et al (1979), has been amply confirmed in reports from four
independent laboratories involving studies of pulsed as well as continuous
wave ultrasound (Haupt et al 1981; Ehlinger et al 1981; Ozawa et al 1984;
Stella et al 1984). Recently further evidence that sister chromatid
exchanges in human lymphocytes are induced by high-intensity pulsed
ultrasound has been presented by Barnett et al (1988), who are now able to
confirm the previous results."

"Free radical production in amniotic fluid and blood
plasma by medical ultrasound, probably following gaseous cavitation, has
been detected by Crum et al (1987). This provides a likely mechanism for the
origin of the DNA damage. Because of these confirmations and a report by
Ellisman et al (1987) that diagnostic levels of ultrasound may disrupt
myelination in neonatal rats, the need for regulation, guidance, and
properly controlled clinical studies is clear."

The implications of premature ovulation after ovarian
ultrasonography, reported by Testart et al, are disturbing. If ultrasound can
affect the adult ovary, what then is the effect of ultrasound on the ova of the
female fetus?

Even if we begin today to carry out a well-controlled
investigation into the delayed long-term effects of obstetric ultrasound it will
be 20 or 30 years before we will know whether ultrasound will be the DES of the
next generation.

Even where there is a medical indication of need the woman
has a right to be informed, and her health care provider has a legal obligation
to advise her, of the potential risks and relevant areas of uncertainty
regarding the latent effects of ultrasound. "Weasel wording", which
implies that proper research has been carried out and no risks found, rather
than a clear statement regarding potential risks is still the norm in most
health care facilities.

The consent form would be invaluable in carrying out an
investigation as to the delayed, long term effects of ultrasound, not just in
the case of obstetrics but for all uses of ultrasound. The consent form offers
several benefits.

It would help to insure
that women will be advised of the risks and areas of uncertainty before
granting consent to diagnostic ultrasound.

It would create a data base
for a long term follow up of exposed offspring.

It would help to protect
the provider from malpractice suits if time proves ultrasound to be
harmful to human development.

It would shift or share the
potential liability by identifying the manufacturer of the device.

American women should not assume that health care providers
always know what is best for them. Information needed by the woman, if her
consent is to be truly informed, must include the fact that no properly
controlled scientific investigation has been carried out to evaluate the delayed
long-term effects of ultrasound.

All of us, whether we are health care providers, scientists
or consumers, hope that time will prove ultrasound to be safe. However, until
well-controlled research has established ultrasound to be without harm women
must be informed of the areas of uncertainty concerning themselves and their
babies.